Atlas FDA

REPROCESSED TROCARS

FDA 510(k) clearance K062497 · decided 2007-01-31

Clearance details

K-number
K062497
Device name
REPROCESSED TROCARS
Applicant
Ascent Healthcare Solutions
Decision
Substantially Equivalent
Date received
2006-08-25
Decision date
2007-01-31
Days to decision
159 days
Clearance type
Traditional
Product code
NLM
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Phoenix, AZ, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Ascent Healthcare Solutions

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Reprocessed Endoscopic Trocars and Sleeves (K201511)Stryker Sustainability Solutions2020-07-31
Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer (K182828)Surgical Instrument Service and Savings, Inc.2019-04-15
Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves (K172097)Renovo, Inc.2017-10-06
Reprocessed Covidien Trocar (K172093)Renovo, Inc.2017-10-05
Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology (K160740)Surgical Instrument Service and Savings, Inc.2016-05-06
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars (K153258)Surgical Instrument Service and Savings (Dba Medline Renewal2016-04-05
REPROCESSED CLOSURE SYSTEM (K133414)Sterilmed, Inc.2014-01-22
REPROCESSED DILATING TIP TROCARS (K132629)Stryker Sustainability Solutions2013-12-31
REPROCESSED ENDOSCOPIC TROCARS (K121240)Sterilmed, Inc.2012-06-11
REPROCESSED ENDOSCOPIC TROCARS (K111002)Sterilmed, Inc.2011-07-18
REPROCESSED TROCARS, MODEL B5LT AND CB5LT (K100080)Ascent Healthcare Solutions2010-03-19
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS (K063788)Ascent Healthcare Solutions2007-10-15

Recalls involving this device

RecordFirmDate
Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are recall (Z-0765-2017)Stryker Sustainability Solutions2016-12-14